Ocular Hypertension, Open Angle Glaucoma
Conditions
Keywords
Glaucoma, Ocular hypertension
Brief summary
The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter, open label, non-randomized, uncontrolled, single group assignment, safety study of subjects with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive study medication for a period of 24-weeks.
Detailed description
This is a multicenter, open label, non-randomized, single-arm, extension safety study to evaluate the long-term safety of SPARC0913. Subjects who completed the prior evaluator-masked clinical non-inferiority Study participated in the current study.
Interventions
DRUGSPARC0913
One drop of SPARC0913 in affected eye once daily for 24 weeks
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged ≥18 years * Willing to participate and giving written informed consent * Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation * Eligible to receive Latanoprost once a daily as monotherapy for treatment of glaucoma
Exclusion criteria
* History of allergic hypersensitivity or poor tolerance to latanoprost * History of Substance abuse or addiction (alcohol drugs) in the past 3 years * History of chronic use of concomitant medications in neurologic or psychiatric illness that would affect assessment of safety and effectiveness of the study medication * Any abnormality preventing IOP measurement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With AEs | 24 weeks | Subjects with treatment emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit) | 24 weeks | From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured |
Countries
United States
Participant flow
Recruitment details
This study was an extension study of previous study conducted by SPARC (CLR\_09\_12). This was open-label, single group assignment long-term safety study. A total of 161 subjects were enrolled in this study. From the start of the study through Week 24 (Visit 7), safety endpoints (TEAEs and change introocular pressure) were evaluated
Pre-assignment details
Subjects received their first dose of the study drug at Visit 1 (Baseline Visit). A total of 149 subjects completed Study Visit 7 (End-of-Evaluations), which met FDA's recommendation of providing safety data for at least 100 subjects for at least 6 months.
Participants by arm
| Arm | Count |
|---|---|
| SPARC0913 Inhaled dose of SPARC0913. Each single dose was administered as 1, 2, 4 and 8 puffs from the inhaler. | 161 |
| Total | 161 |
Baseline characteristics
| Characteristic | SPARC0913 |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 140 / 161 |
| serious Total, serious adverse events | 5 / 161 |
Outcome results
Primary
Number of Subjects With AEs
Subjects with treatment emergent adverse events
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPARC | Number of Subjects With AEs | 140 participants |
Secondary
Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)
From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured
Time frame: 24 weeks
Population: From the start of the study through Week 24 (Visit 7, End of Evaluations), the change in IOP is evaluated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPARC | Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit) | 2.83 mm Hg | Standard Deviation 4.2 |